Alternative to open heart surgery just as effective for patients with common heart condition

Leicester researchers have shown, in a ground-breaking study published in the Journal of the American Medical Association (JAMA), how a less invasive heart procedure for a common condition is just as effective as conventional open-heart surgery.

Research led by the University of Leicester compared Transcatheter Aortic Valve Implantation (TAVI) to conventional surgery in treating severe symptomatic aortic stenosis. It is estimated that 1.5% of UK adults over 55 and 3.5% of those over 75 have this condition, which results in a narrowing of the valve that blood flows through as it leaves the heart.

The UK TAVI trial is the first publicly-funded study of its kind, receiving over £3 million from the National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) programme, and involved every centre in the UK that performs TAVI.

The first TAVI in the UK was performed in Leicester in 2007 by a multidisciplinary team at Glenfield Hospital in Leicester, led by Professor Jan Kovac. In a TAVI procedure, a new valve is threaded through a small tube inserted into an artery in the groin, upper arm or chest. It provides an alternative to open-heart surgery and is now widely used across the UK.

Previous studies have shown TAVI is a safe and effective treatment for people who are not eligible for conventional surgery or at high operative risk. However, this study included patients who were at lower risk and suitable for either procedure. The study found that, one year after treatment, the rates of death from any cause and other important clinical outcomes such as stroke were similar between the TAVI group and the surgery group.

The study included 913 participants – with an average age of 81 – who were randomised to either undergo the TAVI procedure or conventional surgery. Those who underwent TAVI were more likely to experience vascular complications and require pacemakers, while those who underwent surgery were more likely to experience major bleeding. There was a greater improvement in symptoms, functional capacity and quality of life at six weeks in the patients who received TAVI and the quality of life advantage was still present at one year.

William Toff, Professor of Cardiology in the University of Leicester’s Department of Cardiovascular Sciences and the NIHR Leicester Biomedical Research Centre, led the UK TAVI study. Professor Toff said: “It’s great news for patients that TAVI is just as safe and effective as surgery even in patients at lower operative risk. This procedure is much less invasive than conventional approaches. People who would otherwise require open-heart surgery can have this procedure, and as it has a faster recovery time it means a shorter stay in hospital for patients.

“These are extremely encouraging results after one year. However, we shall continue to monitor the participants for at least five years to ensure no late differences in the groups emerge and to assess the durability of the TAVI valves. We hope to publish the five-year results by the end of next year. In the meantime, patient-specific treatment recommendations should continue to be made by a multi-disciplinary heart team.”

‘Effect of transcatheter aortic valve implantation vs surgical aortic valve replacement on all-cause mortality in patients with aortic stenosis: a randomized clinical trial’ is published in the Journal of the American Medical Association.

WATCH: JAMA Deputy Editor Gregory Curfman, MD, gives editorial insight into the UK TAVI trial results and accompanying editorial published in the May 17, 2022, issue of JAMA (open access).